Kornimate/medical-research-clean huggingface dataset:
study of the effect of bg00012 on mri lesions and pharmacokinetics in pediatric subjects with rrms

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective of this study is to evaluate the effect of bg00012 (dimethyl fumarate) on brain magnetic resonance imaging (mri) lesions in pediatric participants with relapsing-remitting multiple sclerosis (rrms). the secondary objectives of this study are to characterize the pharmacokinetics of bg00012 in pediatric participants with rrms and to evaluate the safety and tolerability of bg00012 in pediatric participants with rrms.


Eligibility criteria:
key inclusion criteria: * ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations. * must have a body weight of ≥30 kg at screening and day 1. * must have a diagnosis of rrms according to mcdonald criteria for ms (2010) \[polman 2011\] and international pediatric multiple sclerosis (ms) study group criteria for pediatric ms (2013) \[krupp 2013\]. key exclusion criteria: * primary progressive, secondary progressive, or progressive relapsing ms (as defined by \[lublin and reingold 1996\]). these conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement. * disorders mimicking ms, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders. * history of severe allergic or anaphylactic reactions or known drug hypersensitivity to dimethyl fumarate or fumaric acid esters. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pediatrics
value for cord blood procalcitonin to diagnose early neonatal bacterial infection

Conditions: Neonatal Bacterial Infection

Summary: after birth, in the presence of risk factors for early neonatal bacterial infection (ibnp), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. this decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. these information lack sensitivity and specificity. therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. however, the diagnosis of ibnp posteriori, is often reversed. this attitude is: 1. one source to higher health care costs (hospitalization, additional examinations) 2. selection of the bacterial ecology of the newborn and neonatal services and 3. stress for the newborn and parents


Eligibility criteria:
inclusion criteria: * birth to motherhood. * term \> 34 weeks . * presence of at least one of the factors of major or minor infection risk exclusion criteria: * cord blood sample unavailable. * death in the delivery room * corticosteroids prenatally (modification of cytokine production ) .

Keywords: neonatal bacterial infection procalcitonin
population pharmacokinetic of piperacillin/tazobactam in maternal and neonatal populations

Conditions: Early-Onset Neonatal Sepsis

Summary: the purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin/tazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.


Eligibility criteria:
inclusion criteria: * patients over 18 years old; * pregnant women whose baby are at high risk of developing early-onset sepsis after birth have indications to use preventive or therapeutic antibiotics, and the antibiotics used are pip/tazo； * patients and their families are fully aware of the research content and sign the informed consent form. exclusion criteria: * intolerance or serious adverse reactions to antibiotic use; * patients who stopped using pip/tazo more than 24 hours before delivery; * receiving other systemic trial drugs; * there are other factors that the researchers think are not suitable for inclusion
suicide prevention for justice involved managed care subscribers

Conditions: Suicide and Self-harm

Summary: the goal of this clinical trial is to test the effects of two suicide prevention interventions for individuals released from jail. the main questions it aims to answer are: does the use of caring contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? and will providing training and resources to behavioral health providers improve re-engagement with healthcare services for patients recently released from jail? participants will include (1) subscribers of a managed care organization (mco) and (2) behavioral health providers within the mco system. interventions include sending subscribers caring contacts letters for 6-months following jail release and providing resources and training to behavioral health providers to target healthcare re-engagement and suicide prevention.


Eligibility criteria:
inclusion criteria: * 18+ years old * behavioral health (bh) providers/staff employed at a caresource bh agency exclusion criteria: * none

Keywords: suicidal behavior jail release behavioral health providers suicide training
in-hospital physiotherapy for patients undergoing thoracic surgery - a randomized controlled trial

Conditions: Lung Cancer

Summary: lung cancer is one of the most common types of cancer in the world, and the cancer that causes the most number of deaths. in sweden, about 3700 persons are diagnosed every year. about one fifth of the patients are eligible for surgery. patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery. in australia, new zealand, and the united kingdom, pre- and postoperative physiotherapy is routinely provided for patients undergoing thoracic surgery, but the effects have not been thoroughly investigated. the scientific evidence of the effect of physiotherapy in connection with lung surgery is limited. the treatment typically consists of early mobilisation, breathing exercises and exercises for the shoulders. reeve et al has shown that a postoperative shoulder exercise program can improve function and decrease pain after thoracotomy. breathing exercises has not been found effective in reducing the rate of postoperative pulmonary complications after thoracic surgery. the purpose of this study is to investigate the effect of in-hospital physiotherapy treatment, for patients undergoing thoracic surgery, on physical activity, health related quality of life, pain and lung function.

lung cancer is one of the most common types of cancer in the world, and the cancer that causes the most number of deaths. in sweden, about 3700 persons are diagnosed every year. about one fifth of the patients are eligible for surgery. patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery. in australia, new zealand, and the united kingdom, pre- and postoperative physiotherapy is routinely provided for patients undergoing thoracic surgery, but the effects have not been thoroughly investigated. the scientific evidence of the effect of physiotherapy in connection with lung surgery is limited. the treatment typically consists of early mobilisation, breathing exercises and exercises for the shoulders. reeve et al has shown that a postoperative shoulder exercise program can improve function and decrease pain after thoracotomy. breathing exercises has not been found effective in reducing the rate of postoperative pulmonary complications after thoracic surgery. the purpose of this study is to investigate the effect of in-hospital physiotherapy treatment, for patients undergoing thoracic surgery, on physical activity, health related quality of life, pain and lung function.

Eligibility criteria:
inclusion criteria: * thoracic surgery exclusion criteria: * previous lung volume reducing surgery
identification of factors predictive of tofacitinib's survival in patient with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: regarding tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of tofacitinib drug survival in patients with ra are available. therefore, the primary objective of the defacto study will be to identify the factors predictive of tofacitinib drug survival in patients with ra. as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in french patients with ra.

this is an observational, open-label, prospective, multi-centre, national study designed to evaluate the factors predictive of tofacitinib's survival in patients with rheumatoid arthritis if catastrophisation is described as a distortion of the perception of pain involving a both emotional and cognitive component, pushing the patient to see only the worst, coping involves adaptive strategies by which the patient attempts to find solutions in order to better cope with his/her disease. it has been demonstrated that such behavioural strategies can influence directly or indirectly the intensity of symptoms in patients suffering from chronic disease. therefore, as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in french patients with ra. the duration of this study will be approximately 48 months including a 24-month recruitment period and a 24-month patient follow-up period. patients will be followed prospectively and follow-up visits will be conducted after the initial consultations. no visit or additional test is required by the protocol, since the study is observational

Eligibility criteria:
inclusion criteria: * patient 18 years of age or older * patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist * patient for whom the rheumatologist decides to initiate treatment with tofacitinib * patient informed of the study exclusion criteria: * patient participating in a randomised clinical trial. * patient presenting with a contraindication to prescription of tofacitinib * patients who are investigational site staff members or patients who are pfizer employees directly involved in the conduct of the trial.
the effect of orally administrated nitrate on renal parameters and systemic haemodynamics

Conditions: Hypertension

Summary: treatment with nitrate has shown to lower blood pressure in both healthy subjects and hypertensive patients.beside this nitrate have also shown to decrease arterial stiffness and improve endothelial function.but the effect of nitrate on renal blood flow, kidney function, water and salt balance and vasoactive hormones is still unclear. therefore, the purpose of this study is to investigate the effect of orally administered nitrate on these parameters. this will be done in a double-blinded, placebo-controlled, crossover study. 20 healthy subjects will be treated, in a randomized order, with both potassium nitrate and placebo separated by at least 4 weeks wash-out.

inorganic nitrate reduces blood pressure and improves endothelial function in both healthy subjects and hypertensive patients. this effect is thought to be caused through bioconversion to nitric oxide. thus improving risk factors of cardiovascular decease by increasing vasodilatation, salt regulation and vasoactive hormones.the purpose of this study is to investigate the effect of inorganic nitrate on kidney function, hormones and circulation, which is still unknown. the effect of 4 days treatment with 24 mmol potassium nitrate capsules on heart rate, blood pressure, vasoactive hormones and urinary excretion of sodium and water will be measured in a randomized, placebo controlled, double blinded, crossover study in 20 healthy subjects. each subject attends 2x2 examination days at least 4 weeks apart. the examination days are divided into 8 clearance periods of 30 min. each. the first 3 are baseline periods and in period 4 1 liter of saline is administered to detect any difference in renal parameters after nacl load. if inorganic nitrate supplementation is found to lower blood pressure in addition to favorable renal effects, it could lead to changes in the general treatment of high blood pressure and cardiovascular disease.

Eligibility criteria:
inclusion criteria: * age 18-64 years * bmi 18,5-30 * normotensive * women must use contraception exclusion criteria: * tobacco smoking (non-smokers in more than 3 months can be included) * medicine- or drug abuse * alcohol abuse \>7 units for women \>14 units for men * medical treatment (over the counter medication will evaluated whether or not it is grounds for exclusion) within 2 weeks before the trail period starts except contraception. * pregnancy or nursing * neoplastic disorders * significant clinical signs of heart-, lung-, liver-, kidney-, endocrine- or brain disorders * clinically significant abnormal findings in screening blood samples, urine sample or ecg - donation of blood within 1 month of the first day of investigation. * allergy against compounds in investigational medicine
cardiaplication: a novel antireflux operation

Conditions: Gastroesophageal Reflux Disease

Summary: gastro-esophageal reflux is a commonly encountered problem in infants. after failure of medical therapy, many children are referred for surgical intervention. techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. this is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. we propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the angle of hiss. by plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.


Eligibility criteria:
inclusion criteria: * patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory gerd. exclusion criteria: * inability to obtain consent * surgeon preference

Keywords: gerd fundoplication cardiaplication reflux
oxycodone-naloxone prolonged release tablets in relieving opioid-related constipation

Conditions: Pain

Summary: the primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. the primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Eligibility criteria:
inclusion criteria: * male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. subjects must report constipation caused or aggravated by opioids. exclusion criteria: * females who are pregnant or lactating. * subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study. * subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Keywords: a randomised double-blind double-dummy parallel-group multicentre study to demonstrate improvement in symptoms of constipation moderate to severe, chronic non-malignant pain
the efficacy of zinc as adjunct therapy in the treatment of severe pneumonia in children

Conditions: Pneumonia

Summary: pneumonia is a leading cause of morbidity and mortality in children in developing countries. zinc deficiency leads to impairment in tissue repair and immunodeficiency in children.at least two randomised controlled trials have shown that zinc supplementation improves the outcome of severe pneumonia in children (reducing duration of hospital stay and complications related to pneumonia). however, there are conflicting results from other randomised controlled trials about its efficacy in children with pneumonia.the purpose of the current study is to determine the efficacy of zinc as adjunct therapy for in severe pneumonia in children aged 6-59 months. we hypothesize that the proportion of children who recover from severe pneumonia following zinc adjunct therapy \[(10 mg once daily for seven days) for children aged \<12 months and 20 mg daily for children aged ≥12 months\]will be higher than the proportion of children who recover from placebo therapy.

zinc deficiency is a global nutritional problem affecting people with a low socioeconomic status in developing and developed countries. there is a high prevalence of zinc deficiency in uganda as documented by bitarakwate et al.two clinical studies have shown that zinc supplementation improves the outcome of severe pneumonia in children by reducing duration of hospital stay and complications related to pneumonia. however, there are conflicting results from some previous studies about its usefulness in patients with pneumonia. the objective of this study is to determine the effect of zinc supplement as adjunct therapy in the treatment of severe pneumonia in children less than five years admitted to mulago hospital, kampala, uganda. this will be a randomized, double-blinded, placebo-controlled trial of zinc adjucnt therapy. three hundred and twenty eight children with severe pneumonia will be randomised to receive either zinc (a daily dose of 20 mg for children more than one of age and 10mg for those less than one year or placebo once daily for seven days. the primary outcome will be time taken to :normalisation of respiratory rate, temperature and oxygen saturation. secondary outcome:proportion of study children who will die during the follow up period,proportion of children who develop drug adverse effects data will be analysed using kaplan meir survival curves.

Eligibility criteria:
inclusion criteria: * children aged 6- 59 months with cough, difficult breathing and chest indrawing * written informed consent from the caretaker exclusion criteria: * children with known heart disease * children on medication with zinc supplements * children with obstructive air way disease * children with active measles * known intolerance or allergy to zinc or zinc-containing products

Keywords: zinc placebo severe pneumonia children
the effects of ultrasound-guided prf versus dn in myofascial pain patients

Conditions: Myofascial Pain

Summary: this study aims to compare the effects of pulsed radiofrequency and drying needling and explore the short-term effect of pulsed radiofrequency in treating myofascial pain patients.


Eligibility criteria:
inclusion criteria: * age 18-70 years old, gender unlimited. * myofascial pain diagnosed according to the "simons and travell" criteria. * able to complete treatment and follow-up. * signed inform consent form. exclusion criteria: * history of surgery, trauma, or infection in the pain area. * severe systemic disease, e.g. malignant tumor; severe hepatic, renal, or coagulation disorder; etc. * pregnancy, needle phobia, unable to cooperate. * concurrently receiving pain treatment in other institutions.
a prospective study of fractional flow reserve assessment of intermediate coronary stenoses in severe aortic stenosis

Conditions: Coronary Artery Stenoses; Aortic Stenosis

Summary: coronary artery blockages can reduce blood flow to the heart muscle. fractional flow reserve (ifr or ffr) assessment is an invasive tool used to determine how much blood flow is reduced. the investigators will perform ifr/ffr on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (tavr) and after successful tavr. the investigators will compare pre- and post-tavr ifr/ffr values, and assess short-term outcomes. the investigators hypothesize that ifr/ffr values will be consistently and significantly higher pre-tavr in comparison with post-tavr for the same lesions.

the purpose of the study is to determine whether ifr assessment gives a valid assessment of coronary hemodynamics in patients with severe aortic stenosis. several factors confound the interpretation of fractional flow reserve (ffr) in patients with severe aortic stenosis (as) and intermediate severity coronary stenoses, and the widely accepted cut-off value of 0.80 may not be applicable to this patient population. coronary flow reserve is known to be attenuated under conditions of left ventricular hypertrophy and severe as, with one study showing improvement in coronary flow reserve after aortic valve replacement. left ventricular hypertrophy produces fixed resistance secondary to external compression of the coronary microcirculation. this potentially results in failure to achieve maximal hyperemia with adenosine and can lead to false negative ffr results. neurohormonal influences in aortic stenosis can further attenuate vasodilator response and potentially result in false negative ffr values. both of these conditions result in the potential deferral of lesions which may have been hemodynamically significant in the absence of severe as. at present, there are no studies which have demonstrated validity of ffr measurement in patients with severe as. here, the investigators propose a prospective study of ifr/ffr in patients with as and indeterminate coronary lesions undergoing tavr to understand the hemodynamic consequences of as on ifr/ffr. the investigators hypothesize that ifr/ffr values will be consistently and significantly higher pre-tavr in comparison with post-tavr for the same lesions.

Eligibility criteria:
inclusion criteria: * all patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing tavr work-up. exclusion criteria: * patients with documented intraprocedural hemodynamic instability, shock, or major adverse event (myocardial infarction, aortic rupture/dissection, stroke, left ventricular perforation, cardiac arrest). * contraindication to adenosine, presence of cardiogenic shock, presence of acute coronary syndrome.

Keywords: coronary artery stenoses aortic stenosis